Investigation of Newly Developed 1-piece Convex Baseplates in Subjects With Ileostomy

Coloplast

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Device: Coloplast Test 1; Device: Coloplast Test 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01994876

CP229

Details and patient eligibility

About

To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must comply with the following criteria in order to participate in the investigation:

1. Are at least 18 years of age and have full legal capacity
2. Have had an ileostomy for at least 3 months
3. Have used a convex ostomy appliance for the last month
4. Have given written informed consent
5. Have an ileostomy with a diameter of 33 mm or less
6. Have experience leakage (seeping) under the baseplate at least two times over the last two weeks

Exclusion criteria

Subjects complying with the following criteria must be excluded from participation in the clinical investigation:

1. Have a loop ostomy (also called double-barrel or ostomy with two outlets)
2. Are pregnant or breastfeeding
3. Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
4. Currently receiving or have received, within the last month, systemic or local steroid treatment (adreno-cortical hormone) in the peristomal area
5. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin))
6. Are currently participating in another clinical investigation or has previously participated in this investigation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

First Coloplast Test 1

Experimental group

Description:

The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2

Treatment:

Device: Coloplast Test 1

Device: Coloplast Test 2

First Coloplast Test 2

Experimental group

Description:

The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1

Treatment:

Device: Coloplast Test 1

Device: Coloplast Test 2